Preventing Lack of Iodine During Pregnancy
Information source: University Hospital, Toulouse
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pregnancy
Intervention: potassium iodide (Drug); placebo (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: University Hospital, Toulouse Official(s) and/or principal investigator(s): CARON PHILIPPE, Pr, Principal Investigator, Affiliation: CHU Toulouse WEMEAU Jean-Louis, Pr, Study Chair, Affiliation: CHRU LILLE NICCOLI-SIRE Patricia, Pr, Study Chair, Affiliation: CHU Timone MARSEILLE BRUCKER-DAVIS Francoise, Dr, Study Chair, Affiliation: CHU Nice
Summary
The purpose of this study is to evaluate the efficacy of potassium iodide during pregnancy
on neuro-cognitive development of children followed up until two years.
Clinical Details
Official title: Phase III : Preventing Lack of Iodine During Pregnancy. Effect of Supplying Woman With Potassium Iodine to the Neuro-Cognitive Children Development Until Two Years
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Supplying a daily dose of 200 µg of potassium iodide in comparison with a placebo dose to pregnant woman and evaluate the impact on neuro-cognitive development of children followed up until two years
Secondary outcome: Prevalence of hypothyroxinemia and hypothyroidism during pregnancyChange in the functional thyroid parameters of mother during iodine treatment Comparison of the psychometric development of children , for woman with and without treatment Quantify the iodine supply from the woman to the baby during the breast feeding for woman with and without iodine treatment
Detailed description:
374 patients with pregnancy less 12 weeks amenorrhea
Patients randomized in 2 parallel groups (each group with 187 patients)
- one group with 200 µg of potassium iodide
- one group with placebo
Follow up during 3 years with :
- a selection visit, an inclusion with randomization before 12 weeks amenorrhea
- and follow up visit at the 5th month and 8th month of pregnancy, the day of birth, and
6, 12, and 24 months " post partum "
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Patients with pregnancy less 12 weeks amenorrhea , with clinically normal pregnancy,
unique or twiny
- Patients who agree to take part in the study and able to sign an Informed Consent
Form
Exclusion Criteria:
- Patients receiving a treatment for thyroid affection, or with thyroid pathology
- Patients with a chronic pathology like insulin dependent diabetes or arterial
hypertension
- Patients with a treatment supplying iodine or having had a gynecologic exam with a
iodine solution in the last 30 days
- Patients taking part in another clinical test or in the last 30 days
- Patients with depressive antecedent before pregnancy or taking antidepressant
treatment
- Psychiatric troubles that may interfere with the clinical evaluation
- Patients under special supervision or trusteeship
- No social security cover
Locations and Contacts
Endocrinology - University Hospital, Toulouse 31059, France
Additional Information
Related publications: Caron P, Hoff M, Bazzi S, Dufor A, Faure G, Ghandour I, Lauzu P, Lucas Y, Maraval D, Mignot F, Réssigeac P, Vertongen F, Grangé V. Urinary iodine excretion during normal pregnancy in healthy women living in the southwest of France: correlation with maternal thyroid parameters. Thyroid. 1997 Oct;7(5):749-54. Caron Ph, D Glinoer La fonction thyroïdienne au cours de la grossesse La Thyroïde. De la physiologie cellulaire aux dysfonctionnements. Des concepts à la pratique. Ed Expansion Scientifique - Paris, 2001, 495-500.
Starting date: December 2006
Last updated: October 10, 2011
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